Home NDC 78164-101-35 Hand Sanitizer plus Holder
Product NDC 78164-101
Requested package NDC 78164-101-35
11-digit product format 781640101
Labeler code 78164
Product ID 78164-101_3f042aa7-7546-a06c-e063-6394a90aed31
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride
Dosage form LIQUID
Route TOPICAL
Labeler Gertex Hosiery
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-09-01
Substance BENZALKONIUM CHLORIDE
Active strength .1 g/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Hand Sanitizer plus Holder
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE .1 g/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 78164-101-35 Hand Sanitizer plus Holder 35 mL in 1 BOTTLE LIQUID 35 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 48 of 114 · 2,275 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hand Sanitizer BENZALKONIUM CHLORIDE DGH Pharma, Inc. afeccd10-c7e5-6193-e053-2995a90a9a5a 2025-12-18 Warnings Exact identifier application number: M003 Hand Sanitizer BENZALKONIUM CHLORIDE DGH Pharma, Inc. ae4311f8-fc40-38a7-e053-2a95a90ae829 2025-12-18 Warnings Exact identifier application number: M003 Alcohol ALCOHOL Dynarex Corporation 88c5dcbe-185f-4966-b98b-25d50299e8df 2025-12-18 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE-IODINE TwinMed LLC fc8cb10c-4973-c0bd-e053-6394a90a6fdb 2025-12-18 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE-IODINE TwinMed LLC fcf27cbf-9535-1356-e053-6394a90a0362 2025-12-18 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE-IODINE TwinMed LLC fcf30b3a-c25b-7aaf-e053-6394a90affda 2025-12-18 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Black Raspberry ETHYL ALCOHOL 70% V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 462ab5e8-029a-fe9d-e063-6294a90ac14d 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Clementine Burst ETHYL ALCOHOL 70% V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 462ad5ba-253f-2a30-e063-6294a90a261d 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Honeydew Tart ETHYL ALCOHOL 70% V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 462af072-6709-546f-e063-6294a90aacc8 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Pear Blossom ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 462b1d38-c7fa-992f-e063-6294a90ab78f 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Black Raspberry ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 462b2d3f-67b0-c393-e063-6294a90a208a 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Clementine Burst ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 462b36d0-0a1f-bda8-e063-6294a90a5792 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Honeydew Tart ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 462b39e9-cf8e-3268-e063-6394a90a69c0 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Pear Blossom ETHYL ALCOHOL 70% V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 462a1437-154c-0324-e063-6294a90a1266 2025-12-17 Warnings Exact identifier application number: M003 Alcohol Prep Pads ISOPROPYL ALCOHOL Family Dollar Stores, Inc. 15af30ec-f77d-2f5c-e063-6394a90a0580 2025-12-17 Warnings Exact identifier application number: M003 Signature Select Isopropyl Alcohol Wipes (40 count) ISOPROPYL ALCOHOL Better Living Brands LLC c9efcad4-f85c-4b10-9984-55549a4ff026 2025-12-17 Warnings Exact identifier application number: M003 finipil 4 men only BENZETHONIUM CHLORIDE Equibal, Inc. aba2e3e6-6047-416d-8ca3-44f1033671e3 2025-12-17 Warnings Exact identifier application number: M003 finipil pro/elec BENZETHONIUM CHLORIDE Equibal, Inc. f68aa5db-7a4e-410f-8159-3356d9407d31 2025-12-17 Warnings Exact identifier application number: M003 Made for Men BENZETHONIUM CHLORIDE Equibal, Inc. d12f748d-7dc5-4cd7-9718-ebb47171d58b 2025-12-17 Warnings Exact identifier application number: M003 QuickMend BENZETHONIUM CHLORIDE Equibal, Inc. 9b0c85a4-9727-4940-a934-0b81a7c938cf 2025-12-17 Warnings Exact identifier application number: M003
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 78164-101-35 78164010135 35 mL in 1 BOTTLE (78164-101-35) 35 ml 2025-09-01 No No Current